← Product Code [HRX](/productcode/HRX) · K960046

# SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE (K960046)

_Surgical Dynamics, Inc. · HRX · Apr 2, 1996 · Orthopedic · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960046

## Device Facts

- **Applicant:** Surgical Dynamics, Inc.
- **Product Code:** [HRX](/productcode/HRX.md)
- **Decision Date:** Apr 2, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1100
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct visualization during a laparoscopic procedure.

## Device Story

Device consists of 30K working channel scope, Nucleotome probes (2.5mm, 3.5mm, 4.7mm), IA cannula, and grasping forceps; used for automated laparoscopic discectomy. Scope provides direct visualization of lumbar disc space; Nucleotome probes connect to Nucleotome console for tissue removal. Used in surgical setting by physicians; facilitates disc decompression through minimally invasive laparoscopic access. Longer probe lengths compared to predicate allow for laparoscopic approach; otherwise identical in function and design.

## Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarity to predicate devices.

## Technological Characteristics

Rigid endoscope and instrument set. Materials, design, and energy source identical to predicate. Components include 30K working channel scope, Nucleotome probes (2.5mm, 3.5mm, 4.7mm), IA cannula, and grasping forceps. Probes are longer than predicate versions. No software or electronic algorithm components.

## Regulatory Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

## Predicate Devices

- Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy
- Argus Medical Company Laparoscopic Discectomy Instrument System
- Nucleotome System and Probe Kits

## Submission Summary (Full Text)

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K960046 APR - 2 1996 K960046

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with CFR 807.92 (April 26, 1992), the following information is submitted:

1. Name: Surgical Dynamics, Inc.
Address: 2575 Stanwell Drive
Concord, CA 94520
Telephone: 510 687 2192 extension 509.
Contact: Charmaine Henderson
Date of Summary Preparation: August 1995

2. Name of Device: Surgical Dynamics, Inc. 30K Working Channel Scope and Instrument Kit for Automated Laparoscopic Discectomy
Generic Name: Rigid Endoscope and Instrument Set

3. Predicate device:
Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy
Argus Medical Company Laparoscopic Discectomy Instrument System
Nucleotome System and Probe Kits

4. Device Description:
The Surgical Dynamics 30K Working Channel Scope and Instrument Kit for Laparoscopic Discectomy are comprised of the following components:
30K Working Channel Scope
Nucleotome 2.5 mm Laparoscopic Probe
Nucleotome 3.5 mm Laparoscopic Probe
Nucleotome 4.7 mm Laparoscopic Probe
IA Cannula
Grasping Forceps with Teeth for Laparoscopic Discectomy
The Nucleotome probes are used in conjunction with the Nucleotome console.

5. Intended Use:
The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct

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visualization during a laparoscopic procedure.

6. Technological Characteristics of the Device:

The Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is identical in design, materials and energy source as the predicate device, the Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy. The intended use is the same as the predicate device; Argus Medical Company Laparoscopic Discectomy Instrument System. The Surgical Dynamics 2.5 mm Laparoscopic Probe, Surgical Dynamics 3.5 mm Laparoscopic Probe and the Surgical Dynamics 4.7 mm Laparoscopic Probe are identical in design, materials and energy source to the predicate Surgical Dynamics probes and kits with one exception; the new devices are longer in length.

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**Source:** [https://fda-staging.innolitics.com/device/K960046](https://fda-staging.innolitics.com/device/K960046)

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